Centre de recherche en sante de nouna
Nouna, Burkina Faso
NCT Number: NCT05932992
The investigators propose a pilot randomized controlled trial to train mothers to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.
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Notify Me6 month–59 month
All sexes
Interventional
Not applicable
Nouna, Burkina Faso
While interventions prioritizing rapid weight gain have led to improved survival for children with severe acute malnutrition (SAM), prevention of relapse to SAM after recovery is essential to improve long-term outcomes for children beyond survival. Mothers have been successfully trained to screen for new-onset SAM in community-based settings and perform as well as community health workers for detecting SAM. Here, the investigators propose a pilot randomized controlled trial in which mothers will be trained to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.
SPECIFIC AIM 1: Determine the feasibility of training mothers to screen for relapse among children recovering from SAM compared to standard of care for early detection of relapse and re-entry to care. The investigators hypothesize that relapse will be detected earlier in children whose mothers have been trained to screen for relapse compared to standard of care (no mother screening).
Specific Aim 1A: Determine the burden of post-discharge relapse among children recovered from an episode of SAM in Boromo, Burkina Faso. The investigators hypothesize that >25% of children who have recovered from SAM in the study facilities will relapse within a 6-month period following their discharge.
Specific Aim 1B: Determine the acceptability and feasibility of training mothers to screen for relapse after discharge among children recovered from SAM. the investigators hypothesize that mothers will find MUAC screening acceptable and that training them will be feasible, as demonstrated by time and costs for training, willingness to participate in training, and follow-up in the trial.
SPECIFIC AIM 2: Determine the accuracy of mother-based screening for relapse among children recovering from SAM compared to a gold standard anthropometrist. the investigators hypothesize that mother screening will have a sensitivity and specificity of > 80% for the detection of relapsed SAM (MUAC < 11.5 cm) compared to screening by a trained anthropometrist.
the investigators anticipate that the result of this pilot will provide evidence supporting the acceptability, feasibility, and accuracy of mother screening for relapse among children with SAM. The data generated during this pilot will be used to support the development of a full-scale randomized controlled trial and will be used as preliminary data supporting an R01-level NIH application. These data will help establish a new line of work for our research team in the management of acute malnutrition, which builds on existing expertise in randomized controlled trials and antibiotic-based interventions for child survival and reduction of morbidity, including as part of the management of uncomplicated SAM.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mothers will be trained to perform MUAC weekly on their children
Time frame: 6 months
Time to relapse using a log-rank test with a term for randomized treatment assignment will be used.
Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC < 11.5 cm and / or weight-for-height Z-scores WHZ < -3 SD)
Time frame: 6 months
Weight-for-height Z-score (WHZ) is the number of standard deviations a child's weight-for-height differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher WHZ values indicate better nutritional status, while lower values indicate greater wasting. WHZ below -2 SD indicates wasting, and WHZ below -3 SD indicates severe wasting/severe acute malnutrition. There is no fixed minimum or maximum value for this standardized Z-score.
Time frame: 6 months
Weight-for-age Z-score (WAZ) is the number of standard deviations a child's weight-for-age differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher WAZ values indicate better nutritional status, while lower values indicate greater underweight. WAZ below -2 SD indicates underweight, and WAZ below -3 SD indicates severe underweight. There is no fixed minimum or maximum value for this standardized Z-score.
Time frame: 6 months
Height-for-age Z-score (HAZ) is the number of standard deviations a child's height-for-age differs from the median of the WHO Child Growth Standards reference population. A Z-score of 0 represents the reference population median. Higher HAZ values indicate better linear growth, while lower values indicate greater stunting. HAZ below -2 SD indicates stunting, and HAZ below -3 SD indicates severe stunting. There is no fixed minimum or maximum value for this standardized Z-score.
University of California, San Francisco
Other
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